TY - JOUR
T1 - Systematic versus on-demand early palliative care
T2 - results from a multicentre, randomised clinical trial
AU - Maltoni, Marco Cesare
AU - Scarpi, Emanuela
AU - Dall'Agata, Monia
AU - Zagonel, Vittorina
AU - Bertè, Raffaella
AU - Ferrari, Daris
AU - Broglia, Chiara Maria Giovann
AU - Bortolussi, Roberto
AU - Trentin, Leonardo
AU - Valgiusti, Martina
AU - Pini, Sara
AU - Farolfi, Alberto
AU - Casadei Gardini, Andrea
AU - Nanni, Oriana
AU - Amadori, Dino
AU - Frassineti, Giovanni Luca Paolo
AU - Sansoni, E.
AU - Ragazzini, Angela
AU - Ruscelli, Silvia
AU - Crivellari, Gino
AU - Galiano, A.
AU - Rodriquenz, Maria Grazia
AU - Biasini, Claudia
AU - Porzio, Rosa
AU - Pittureri, Cristina
AU - Amaducci, E.
AU - Faedi, Marina
AU - Codecà, Carla
AU - Crepaldi, Francesca
AU - Pedrazzoli, Paolo
AU - Bramanti, Alfina
AU - Buonadonna, Angela
AU - Garetto, Ferdinando
AU - Comandone, A.
AU - Giordano, M.
AU - Luchena, Giovanna
AU - Luzzani, Massimo
AU - Cifatte, Chiara
AU - Pino, M. S.
AU - Zoccali, Sonia
AU - Cattaneo, M. T.
AU - Dalu, Davide
AU - Sozzi, Pietro
AU - Gauna, Roberta
AU - Alquati, Sara
AU - Costantini, Massimo
AU - Quadrini, S.
AU - Narducci, Filomena
AU - Mastromauro, Cataldo
AU - Scognamiglio, Rodolfo
AU - Degiovanni, D.
AU - Negri, Federica
AU - Caraceni, Augusto Tommaso
AU - Montanari, L.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Background Early palliative care (EPC) in oncology has been shown to have a positive impact on clinical outcome, quality-of-care outcomes, and costs. However, the optimal way for activating EPC has yet to be defined. Methods This prospective, multicentre, randomised study was conducted on 207 outpatients with metastatic or locally advanced inoperable pancreatic cancer. Patients were randomised to receive ‘standard cancer care plus on-demand EPC’ (n = 100) or ‘standard cancer care plus systematic EPC’ (n = 107). Primary outcome was change in quality of life (QoL) evaluated through the Functional Assessment of Cancer Therapy – Hepatobiliary questionnaire between baseline (T0) and after 12 weeks (T1), in particular the integration of physical, functional, and Hepatic Cancer Subscale (HCS) combined in the Trial Outcome Index (TOI). Patient mood, survival, relatives' satisfaction with care, and indicators of aggressiveness of care were also evaluated. Findings The mean changes in TOI score and HCS score between T0 and T1 were −4.47 and −0.63, with a difference between groups of 3.83 (95% confidence interval [CI] 0.10–7.57) (p = 0.041), and −2.23 and 0.28 (difference between groups of 2.51, 95% CI 0.40–4.61, p = 0.013), in favour of interventional group. QoL scores at T1 of TOI scale and HCS were 84.4 versus 78.1 (p = 0.022) and 52.0 versus 48.2 (p = 0.008), respectively, for interventional and standard arm. Until February 2016, 143 (76.9%) of the 186 evaluable patients had died. There was no difference in overall survival between treatment arms. Interpretations Systematic EPC in advanced pancreatic cancer patients significantly improved QoL with respect to on-demand EPC.
AB - Background Early palliative care (EPC) in oncology has been shown to have a positive impact on clinical outcome, quality-of-care outcomes, and costs. However, the optimal way for activating EPC has yet to be defined. Methods This prospective, multicentre, randomised study was conducted on 207 outpatients with metastatic or locally advanced inoperable pancreatic cancer. Patients were randomised to receive ‘standard cancer care plus on-demand EPC’ (n = 100) or ‘standard cancer care plus systematic EPC’ (n = 107). Primary outcome was change in quality of life (QoL) evaluated through the Functional Assessment of Cancer Therapy – Hepatobiliary questionnaire between baseline (T0) and after 12 weeks (T1), in particular the integration of physical, functional, and Hepatic Cancer Subscale (HCS) combined in the Trial Outcome Index (TOI). Patient mood, survival, relatives' satisfaction with care, and indicators of aggressiveness of care were also evaluated. Findings The mean changes in TOI score and HCS score between T0 and T1 were −4.47 and −0.63, with a difference between groups of 3.83 (95% confidence interval [CI] 0.10–7.57) (p = 0.041), and −2.23 and 0.28 (difference between groups of 2.51, 95% CI 0.40–4.61, p = 0.013), in favour of interventional group. QoL scores at T1 of TOI scale and HCS were 84.4 versus 78.1 (p = 0.022) and 52.0 versus 48.2 (p = 0.008), respectively, for interventional and standard arm. Until February 2016, 143 (76.9%) of the 186 evaluable patients had died. There was no difference in overall survival between treatment arms. Interpretations Systematic EPC in advanced pancreatic cancer patients significantly improved QoL with respect to on-demand EPC.
KW - Early palliative care
KW - Quality of care
KW - Quality of life
KW - cancer pain
UR - http://www.scopus.com/inward/record.url?scp=84979530275&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84979530275&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2016.06.007
DO - 10.1016/j.ejca.2016.06.007
M3 - Article
VL - 65
SP - 61
EP - 68
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
ER -